|

Novel Bipolar Radiofrequency Ablation Knife in Esophageal Lesions

RECRUITINGSponsored by Baylor College of Medicine
Actively Recruiting
SponsorBaylor College of Medicine
Started2024-10-15
Est. completion2025-06-30
Eligibility
Age18 Years+
Healthy vol.Accepted
Locations1 site

Summary

Both Baylor St Luke's Medical Center and Mayo Scottsdale are considered endoscopic submucosal dissection (ESD) centers of excellence. The investigators at Baylor College of Medicine have previously reported our Esophageal ESD experience using the monopolar current knife. Moreover, the research team have previously reported on the clinical efficacy of the bipolar RFA knife during per-oral endoscopic myotomy (POEM) and colonic ESD. The goal of our study is to prospectively evaluate the efficacy, safety and feasibility of Esophageal ESD using a novel Bipolar-Current ESD device.

Eligibility

Age: 18 Years+Healthy volunteers accepted
Inclusion Criteria:

* Patient is \>18 years of age
* Patient can provide informed consent
* Patient is referred for resection of precancerous lesions meeting the following criteria:

  * Mucosal based polyp
  * Located gastroesophageal junction (GEJ) or proximal to GEJ
  * No previous endoscopic resection attempted (EMR or ESD)

Exclusion Criteria:

* Patients with International Normalized Ratio (INR) \>1.5 or Platelets \<50,000
* Lesions extending past GEJ
* Subepithelial lesions

Conditions5

Bipolar ElectrocauteryCancerEndoscopic Submucosal DissectionEsophageal NeoplasmEsophageal Polyp

Locations1 site

Baylor College of Medicine
Houston, Texas, 77030
Michael Mercado713-798-3606Michael.Mercado@bcm.edu

Browse More Trials

Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.

This site does not provide medical advice. Always consult your doctor before considering enrollment in a clinical trial. Learn more on our About page.